Aethlon Medical (NSDQ:AEMD) said today that it won an investigational device exemption from the FDA for an early feasibility study of its Hemopurifier device in patients with head and neck cancer in combination with the standard pembrolizumab (Keytruda) care.
San Diego-based Aethlon said the small trial will enroll 10 to 12 patients with advanced head and neck cancer who can’t be treated with surgery or radiation. The study’s primary endpoint will be an unspecified safety measure, with secondary endpoints including measures of exosome clearance and characterization, along with response and survival rates. The company said more details on the trial will be released in the future.
Aethlon’s Hemopurifier device is a single-use, disposable cartridge designed to target and filter out viruses or tumor-secreted exosomes. Blood flows through the cartridge into nearly 3,000 hollow fibers with pores 250nm in diameter. A pressure differential in the first third of the fiber is designed to push particles below 250 nanometers through the pores into a space between the fibers and the cartridge.
After the particles are pushed between the fibers and cartridge, an affinity agent binds to a disease-specific structure associated with viruses. The structure is something viruses co-opt from the host’s own cells during replication to avoid detection from the host’s immune system. But within the device, that signature is what binds viruses to the cartridge. Everything else continues to flow through the device.
The Hemopurifier won FDA breakthrough designation for the treatment of individuals with “advanced or metastatic cancer who are either unresponsive or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease,” according to a news release.
In June 2017, the Hemopurifier received an Expedited Access Pathway designation from the FDA after an early feasibility study demonstrated that the system was well tolerated with patients with end-stage renal disease who were also infected with Hepatitis C. There were also no device-related adverse events, according to Aethlon.
“This IDE approval is a critical first step in our plans to develop the Hemopurifier for applications in oncology” CEO Dr. Timothy Rodell said in prepared remarks. “We believe that the clearance of immunosuppressive tumor-derived exosomes has the potential to improve response rates to these already game-changing immuno-oncology agents. Our Breakthrough Designation has allowed us to move very quickly with rapid, frequent and helpful communication with the FDA and clearly demonstrates the value of the Breakthrough program.”
Shares of AEMD were up +14.3% at 29¢ per share in mid-afternoon trading.